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Clinical Trials/NCT06506929
NCT06506929
Recruiting
Not Applicable

The Effect of Task Specific Physical Therapy for Persons With Advanced Multiple Sclerosis

Hunter College of City University of New York1 site in 1 country15 target enrollmentJuly 10, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Hunter College of City University of New York
Enrollment
15
Locations
1
Primary Endpoint
Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The purpose of this study is to find effective physical therapy treatments for individuals who have severe multiple sclerosis. Physical therapy treatments for mild-to-moderate multiple sclerosis exists, however, very limited research has been done for physical therapy for severe multiple sclerosis (MS). In this study 10 participants diagnosed with severe MS will engage in 1-hour physical therapy sessions twice a week for 6 weeks to address limitations in standing, balancing, and bed mobility.

Detailed Description

The purpose of this study is to investigate the feasibility, safety, and efficacy of task-specific physical therapy for persons with severe MS. The hypothesize for this study that a task-specific physical therapy program is safe, feasible, and effective in persons with severe MS. Multiple studies have confirmed the effectiveness of task specific physical therapy for persons with MS. However,MS is a progressive disease which can lead to mild to severe disability and the studies examining the effectiveness of task specific therapy have only been conducted on persons with mild to moderate MS impairments. The small amount of research on physical therapy for persons with severe disability due to MS has only looked at the use of generalized conditioning exercises(1). Task specific therapy has been shown to be effective in persons with severe disability in non-MS neurologic disorders.(2) The effectiveness of task specific exercises on persons with severe MS not been studied. Based on the previous scientific evidence of the effectiveness of task-specific physical therapy in MS subjects with mild-to-moderate disability, there is strong scientific justification for conducting a trial of task specific therapy on persons with severe disability due to MS. The results of this study will be presented at various conferences attended by physical therapists as well as other health care practitioners who specialize in MS care, including the American Physical Therapy Combined Sections Meeting, as well as the Consortium of Multiple Sclerosis Centers annual meeting. Additionally, upon completion of the study, we will submit a manuscript to the appropriate peer review journal.

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
January 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Hunter College of City University of New York
Responsible Party
Principal Investigator
Principal Investigator

Herb Karpatkin

Associate professor

Hunter College of City University of New York

Eligibility Criteria

Inclusion Criteria

  • definitive diagnosis of Multiple Sclerosis
  • Expanded Disability Status Scale (EDSS) of 7.0-8.0
  • Ability to read, understand , and sign an informed consent -

Exclusion Criteria

  • evidence of MS exacerbation in the 4 weeks prior to starting the study
  • any orthopedic, cardiopulmonary, or non-MS neurologic symptoms that will interfere with their ability to participate in the study

Outcomes

Primary Outcomes

Multiple Sclerosis Physical Frailty Functional Assessment (MSPFFA)

Time Frame: Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.

Assessment of ability to perform functional mobility tasks. The MSPFFA is a 14 item ordinal scale; the maximum score is a 56, minimom score is 14. The higher the score, the better the function and the less physically frail the person being tested is considered to be.

Secondary Outcomes

  • Multiple Sclerosis Impact Scale-29 (MSIS29)(Will be administered twice, once at pre-intervention and once at post-intervention. The length of the intervention is 6 weeks.)

Study Sites (1)

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